Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K203072
    Manufacturer
    Date Cleared
    2022-01-19

    (467 days)

    Product Code
    Regulation Number
    872.3920
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Franz Zirconia Dental Crown

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

    Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

    Franz Dental Zirconia Crown is intended to be a replacement for a natural tooth.

    Device Description

    Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function.

    Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

    Franz Zirconia Dental Crown is intended to be a replacement for a natural tooth. After finalizing the Franz Zirconia Dental Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

    To achieve esthetics and required value and chroma of the surrounding natural teeth the Franz Zirconia Dental Crown is suitable for cut-back (veneering) or stain and glaze techniques.

    The design of the Franz Zirconia Dental Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using or supported third party CAD systems. The crown, once ordered, is sent electronically to one of Franz's centralized milling centers for fabrication.

    AI/ML Overview

    The Franz Zirconia Dental Crown is a dental prosthesis for partially edentulous patients to restore chewing function. It is a single crown cemented to an artificial or natural tooth abutment.

    Here's a breakdown of the acceptance criteria and supporting studies:

    1. Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance (Franz Zirconia Dental Crown)Predicate Device Performance (NobelProcera HT ML Full Contour Zirconia Crown)
    Biaxial Flexural Strength (MPa) (sintered)1061 (SD 90)1092 (SD 112)
    Fracture Toughness (MPam0.5)6.44Unknown
    Thermal Expansion (um/m°C)9.9510.80
    Chemical Solubility in Water (ug/cm²)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1